US8641683B2 - Injection device - Google Patents

Abstract

An injection device for injection of set doses of medicine from a cartridge has a nut that is screwed up along a threaded piston rod during a dose setting operation. The nut is screwed along the piston rod by rotating a dose setting member. A rotational coupling mechanism includes an axially displaceable coupling member which is rotated as a function of axial displacement. During dose setting, the nut is allowed to rotate relative to the coupling member. During injection, the coupling member is rotationally locked to the nut. This provides a dose setting and injection mechanism wherein the nut member is both rotated during dose setting and during injection.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No. 12/571,721 filed Oct. 1, 2009 (Notice of Allowance received Dec. 7, 2011), which is a Continuation of U.S. application Ser. No. 11/911,871 filed Oct. 18, 2007 (Abandoned) which is a 35 U.S.C. §371 national stage application of International Patent Application PCT/EP2006/061748 (published as WO 2006/114396), filed Apr. 21, 2006, which claimed priority of Danish Patent Application PA 2005 00589, filed Apr. 24, 2005; this application further claims priority under 35 U.S.C. §119 of U.S. Provisional Application 60/676,713, filed May 2, 2005, the contents of the above-named applications are incorporated herein by reference.

The present invention relates to syringes having a piston drive element for engaging and moving a piston within a medication cartridge, by which a dose can be set by rotating a nut along the piston drive element during dose setting, and wherein a set dose can be expelled by driving the nut to its initial position.

BACKGROUND OF THE INVENTION

An almost classic pen which adopts the above described dose setting and injecting scheme is described in EP 327 910.

By setting a dose on this pen a tubular member forming an injection button is screwed up along a threaded piston rod a distance corresponding to the distance said piston rod must be moved to inject the set dose. The tubular member simply forms a nut which is during the dose setting screwed away form a stop and which is during the injection pressed back to abutment with said stop and the force exerted on the button is directly transmitted to the a piston closing one end of an ampoule in the syringe which ampoule contains the medicament to be injected. When the piston is pressed into the ampoule the medicament is pressed out through a needle mounted through a closure at the other end of the ampoule.

By time it has been wanted to store larger amount in the ampoules, typically 3 ml instead of 1.5 ml. As it has not been appropriate to make the syringe longer the ampoule is instead given a larger diameter, i.e. the area of the piston facing the medicament in the ampoule has been doubled and consequently the force which has to be exerted on the piston to provide the same pressure as previously inside the ampoule has been doubled. Further the distance the piston has to be moved to inject one unit of the medicament has been halved.

This development is not quite favourable, as especially users having reduced finger strength have their difficulties in pressing the injection button, a problem that is further increased when still thinner needles are used to reduce the pain by injection. Also with quite small movements of the button it is difficult to feel whether the button is moved at all and by injection of one unit from a 3 ml ampoule the piston and consequently the injection button has to be moved only about 0.1 mm.

Consequently a wish for a gearing between the injection button and the piston has occurred so that the button has a larger stroke than has the piston. By such a gearing the movement of the injection button is made larger and the force, which has to be exerted on the injection button, is correspondingly reduced.

In EP 608 343 a gearing is obtained by the fact that a dose setting element is screwed up along a spindle having a thread with a high pitch. When said dose setting element is pressed back in its axial direction the thread will induce a rotation of said dose setting element, which rotation is via a coupling transmitted to a driver nut with a fine pitch which driver nut will force a threaded not rotatable piston rod forward.

A similar gearing is provided in WO 99/38554 wherein the thread with the high pitch is cut in the outer surface of a dose setting member and is engaged by a mating thread on the inner side of the cylindrical housing. However, by this kind of gearing relative large surfaces are sliding over each other so that most of the transformed force is lost due to friction between the sliding surfaces. Therefore a traditional gearing using mutual engaging gear wheels and racks is preferred.

From WO 96/26754 is known an injection device wherein two integrated gear wheels engages a rack fixed in the housing and a rack inside a plunger, respectively. When the plunger is moved axially in the housing the rack inside this plunger can drive the first gear wheel to make the other integral gear wheel move along the fixed rack in the housing. Thereby the gear wheel is moved in the direction of the plunger movement but a shorter distance than is this plunger and this axial movement of the integrated gear wheels is via a housing encompassing said gear wheels transmitted to a piston rod which presses the piston of an ampoule further into this ampoule. However, the rack inside the plunger is one of a number axial racks provided inside said plunger. These racks alternate with untoothed recesses, which allow axial movement of the plunger without the first gear wheel being in engagement with a rack in this plunger. This arrangement is provided to allow the plunger to be moved in a direction out of the housing when a dose is set. When the plunger is rotated to set a dose it is moved outward a distance corresponding to one unit during the part of the rotation where the first gear wheel passes the untoothed recess, thereafter the first gear wheel engages one of the racks so the set unit can be injected, or the rotation can be continued to make the first gear wheel pass the next recess during which passing the set dose is increased by one more unit and so on until a dose with the wanted number of units is set.

A disadvantage by this construction is that the teeth of the racks and gearwheels alternating have to be brought in and out of engagement with each other with the inherit danger of clashing. As only a few racks separated by intermediary untoothed recess can be placed along the inner surface of the plunger only few increments can be made during a 360° rotation.

In U.S. Pat. No. 6,663,602 is disclosed an injection device, wherein a direct gearing, i.e. a gearing by which more transformations of rotational movement to linear movement and linear movement to rotational movement are avoided, between the injection button and the piston rod.

The injection device shown in U.S. Pat. No. 6,663,602 comprises a housing wherein a piston rod threaded with a first pitch is non rotatable but longitudinally displaceable guided, a nut engaging the thread of the piston rod which nut can be screwed along the threaded piston rod away from a defined position in the housing to set a dose and can be pressed back to said defined position carrying the piston rod with it when the set dose is injected, a dose setting member which can be screwed outward in the housing along a thread with a second pitch to lift an injection button with it up from the proximal end of the housing. This injection device is provided with a gearbox which provides a gearing between the axial movements of the injection button and the nut relative to the housing which gearing has a gearing ratio corresponding to the ratio of said second and first pitch.

Although broadly being considered state of the art, the injection device disclosed in U.S. Pat. No. 6,663,602 presents important mechanical constraints due to the construction principle of the linear gearing system which acts during dosing. According to the injection device of U.S. Pat. No. 6,663,602, the length of the nut/piston rod assembly is increased during the dose setting by rotating the nut in a thread on the piston rod. During dosing, the linear displacement of the nut and the injection button are coupled such that there is proportionality between the movement of the nut and the injection button, the proportionality given by the transmission ratio of the gear box. As the nut is rotationally confined relatively to the piston rod during dosing, the translation of the nut corresponds to the translation of the piston rod and thus ultimately to the dose of medication administered.

As the gear is an integrated part of the construction and as the gear can only be designed to certain transmission ratios, the gear implies important constraints on the obtainable ratio of movement of the injection button relative to the movement of the piston. Due to the direct proportionality between the movement of the piston rod and the administered dose of medication, the same syringe can not easily be adapted to different medications. Although adaptation is possible by changing the transmission ratio of the linear gear, this solution will in general be very complex and imply a complete redesign of the syringe.

DISCLOSURE OF THE INVENTION

The injection devices disclosed in U.S. Pat. No. 6,663,602 comprises dose setting and injection mechanisms wherein the nut is held rotationally fixed during dose delivery. However, according to the present invention, the nut may be rotated relative to the housing, also during dose delivery.

According to one aspect of the present invention, the injection device comprises:

• a. a housing for a dose setting and injecting mechanism, the housing having a proximal end and a distal end,
• b. a rotatable dose setting member,
• c. an axially displaceable piston rod having a first thread and an additional longitudinally extending track,
• d. a central opening in the housing for engaging the additional longitudinally extending track of the piston rod, thus guiding the angular movement of the piston rod during axial translation of the piston rod,
• e. a threaded nut engaging the first thread of the piston rod, the nut being rotatably locked to the dose setting member during dose setting,
• f. a rotational coupling mechanism having a coupling member which is axially displaceable from a first position to a second position, the rotational coupling mechanism allowing rotational movement of the nut relative to the coupling member during dose setting while preventing rotational movement during injection. The coupling member is rotationally coupled to the housing so as to be urged to rotate as a function of axial displacement of the coupling member relative to the housing during at least a part of the axial displacement from said first to said second position.

According to such a configuration, a prolongation or reduction of the stroke of the injection button compared to the stroke of the piston rod may be obtained. Further, as this configuration implies a change in the rate of rotation of the dose setting member for a given dose to be injected, a dose scale reading with a different layout may be obtained. In this way, a scale reading with increased distance between consecutive numbers may be obtained, which provides the possibility of increasing the font size of the labels of the scale reading. Also, this configuration provides the possibility of fine tuning the gearing ratio, if the injection device is so configured.

According to a second aspect of the invention, the dose setting member is axially displaceable as a result of rotation of the dose setting member relative to the housing, while the coupling member is coupled to the dose setting member such that axial displacement of the dose setting member substantially corresponds to axial displacement of the coupling member.

According to a third aspect of the invention, the coupling member has a thread and is threadedly engaged with a helical thread disposed in the housing, the thread of the housing having a constant pitch. According to this aspect, a particularly simple solution is obtained.

According to a fourth aspect of the invention, the coupling member has a thread which engage a longitudinally extending track disposed in the housing wherein the longitudinally extending track has a variable pitch along the extension of the track. According to this aspect, the rotation of the dose setting member is nonlinear with respect to the various specific dose selections. Thus, a dose setting member with a nonlinear scale is obtainable, e.g. a scale can be provided having comparable larger steps for smaller doses to be injected than for larger doses. This implies improved resolution in the low range of injectable doses. Also, an injection button can be provided having a stroke that is nonlinear with respect to the specific amount of drug to be injected, e.g. having a prolonged stroke for smaller doses compared to the solutions provided for in U.S. Pat. No. 6,663,602.

According to a fifth aspect of the invention, the rotational coupling mechanism comprises an incremental feedback mechanism providing incremental clicks during dose setting corresponding to dose volume. This aspect provides an easy adjustment of the rotational movement of the dose setting drum for each click, relatively to the housing part. In combination with the third aspect, an increase or a decrease of distance between the numbers on the dose setting drum or dose setting scale and thus the rotation for each click can be varied by choosing a specific pitch of the thread of the housing which engages the thread of the coupling member. By varying the inclination of the track along the extension of the track, it is possible to vary the rotation per click in a nonlinear way.

According to a sixth aspect of the invention, an injection button is operatively connected to a gear box assembly coupling axial movement of the injection button with axial movement of the nut. A gearing between the movements of the injection button and the nut may be obtained by the gearbox comprising at least one gear wheel carried by a connector which projects from the gear box longitudinally displaceable but non rotatable relative to said gearbox and is integral with the nut, a first rack integral with a first element of the gearbox, which element is rotational but not longitudinally displaceable relative to the housing, and second element carrying a second rack projecting from said gearbox longitudinally displaceable but non rotatable relative to said first element and being coupled to the injection button to follow longitudinal movements of said button, the at least one gear wheel engaging the first and the second rack, respectively, and being dimensioned to provide a gearing by which a longitudinal movement of the second rack is transformed to a longitudinal movement of the connector with a gearing ratio for the mentioned longitudinal movements of the second rack and the connector relative to the housing, which gearing ratio substantially corresponds to the ratio of said second to said first pitch.

In such a device only the forces necessary to drive the dose setting member are transformed by a thread with a high pitch whereas the forces necessary to move the piston by injection is transmitted to said piston through a conventional gear with constantly engaging gears and racks.

In a seventh aspect of the invention, the piston rod is provided with a stop for the movement of the nut along the thread of said piston rod, thereby forming an end-of-content stop. This way a dose setting limiter is provided in the classic way, which involves no additional members to prevent setting of a dose exceeding the amount of liquid left in the ampoule.

According to an eighth aspect of the invention, the additional longitudinally extending track on the piston rod is helically disposed on the external surface of the piston rod thereby forming a second thread on the piston rod. By forming this track in a helical fashion, the piston rod is rotated as a result of axial displacement of the piston rod relative to the housing. By rotating the piston rod and the coupling member a similar angle during dosing, it is possible to set smaller or bigger dosevolume per click, and still have an EOC (End-Of-Content) stop between the piston rod and the nut.

As used herein, the term “drug delivery device” according to the instant invention shall mean a single-dose or multi-dose, disposable or re-useable device designed to dispense a selected dose of a medicinal product, preferably multiple selected doses, e.g. insulin, growth hormones, low molecular weight heparins, and their analogues and/or derivatives etc. Said device may be of any shape, e.g. compact or pen-type. Dose delivery may be provided through a mechanical (optionally manual) or electrical drive mechanism or stored energy drive mechanism, such as a spring, etc. Dose selection may be provided through a manual mechanism or electronic mechanism. Additionally, said device may contain components designed to monitor physiological properties such as blood glucose levels, etc. Furthermore, the said device may comprise a needle or may be needle-free. In particular, preferred embodiment the term drug delivery device shall mean a disposable multi-dose pen-type device having mechanical and manual dose delivery and dose selection mechanisms, which is designed for regular use by persons without formal medical training such as patients. Preferably, the drug delivery device is of the injector-type.

The term “housing” according to instant invention shall preferably mean an exterior housing (“main housing”, “body”, “shell”) or interior housing (“inner body”, “insert”) having internal and external threads. The housing may be designed to enable the safe, correct, and comfortable handling of the drug delivery device or any of its mechanisms. Usually, it is designed to house, fix, protect, guide, and/or engage with any of the inner components of the drug delivery device (e.g., the drive mechanism, cartridge, plunger, piston rod) by limiting the exposure to contaminants, such as liquid, dust, dirt etc. In general, the housing may be unitary or a multipart component of tubular or non-tubular shape. Usually, the exterior housing serves to house a cartridge from which a number of doses of a medicinal product may by dispensed. However, a cartridge may be directly coupled to the housing so as to be partly or fully external to the housing.

The term “engaged” according to instant invention shall particularly mean the interlocking of two or more components of the drive mechanism/drug delivery device, e.g. a spline or thread connection, preferably the interlocking of helical threads of components (“threadedly engaged”). The term “engaged” encompasses the use of intermediary components coupling threadedly engaged threads.

The term “thread” according to instant invention shall preferably mean a full or part thread, e.g., a cylindrical spiral rib/groove, usually of helical nature or comprising linear inclined parts, located on the internal and/or external surface of a component of the drug delivery device (“internal thread” and/or “external thread”), having an essentially triangular or square or rounded section designed to allow continuous free rotational and/or axial movement between components. Optionally, a thread may be further designed to prevent rotational or axial movement of certain components in one direction.

The term “dose setting member” according to instant invention shall mean an essentially tubular component of essentially circular cross-section having either: a) both an internal and external thread, or b) an internal thread, or c) an external thread. The dose setting member may be designed to indicate a selected dose of a dispensable product. This may be achieved by use of markings, symbols, numerals, etc., e.g. printed on the external surface of the dose setting member or an odometer, or the like. Also, a separate dose scale may be used, either comprising a mechanical or an electronic display.

The term “lead” according to instant invention shall preferably mean the axial distance a nut would advance in one complete revolution; preferably “lead” shall mean the axial distance through which a component having a helical thread, i.e. dose setting member, nut, piston rod, etc., of the drive mechanism travels during one rotation. Therefore lead is a function of the pitch of the thread of the relevant component.

The term “pitch” according to instant invention shall preferably mean the distance between consecutive contours on a helical thread, measured parallel to the axis of the helical thread.

The term “piston rod” according to instant invention shall mean a component adapted to operate through/within the housing, designed to translate axial movement through/within the drug delivery device, preferably from the nut to the piston, for the purpose of discharging/dispensing an injectable product. Said piston rod may be flexible or not. It may be a simple rod, a lead-screw, or the like. The “piston rod” according to instant invention shall further mean a component having a non-circular cross-section and preferably having one or more threads located partly or fully extending along its length. It may be made of any suitable material known by a person skilled in the art.

The term “incremental feedback mechanism” according to instant invention shall mean a mechanism providing the dose setting to occur in a number of discrete incremental steps, e.g. one incremental click for each international unit being set, the incremental feedback mechanism preferably providing a tactile or audible click which can be sensed or heard by a user operating the pen.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention is described in further details with references to the drawing, wherein

FIG. 1 schematically shows a sectional view of an injection device according to the invention, and

FIG. 2 shows schematically a sectional view of the gear box along the line I-I inFIG. 1,

FIG. 3 shows a longitudinal sectional view in the dose setting part of another embodiment of an injection device according to the invention,

FIG. 4 shows a longitudinal sectional view perpendicular to the view inFIG. 3,

FIG. 5 shows an exploded view of the of the device shown inFIGS. 3 and 4,

FIG. 6ashows a large scale view of thetubular part105 ofFIG. 5 according to one embodiment of the invention, and

FIG. 6bshows a large scale view of thecorresponding part105 of a prior art injection device.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

The device shown in the appended drawings is shown as an injector pen, which pen has an elongated body with a central axis. However, other forms are within the scope of the invention.

In the device shown inFIG. 1 an elongatedcylindrical housing1 has apartitioning wall2 which divides the housing in a compartment containing a dose setting mechanism and acompartment3 designed for the accommodation of a not shown ampoule. Thepartitioning wall2 is provided with an opening extending there through. Alternatively, the wall may be replaced by an insert which is secured against rotational and axial motion with respect to the main structure of thehousing1, the opening being formed in said insert. Apiston rod4 having afirst thread4aand an additional longitudinally extendingtrack4bformed in or on thepiston rod4, extends through theopening2b, which is provided with one or more ribs which mates and engages the additional longitudinal extendingtrack4b.

In accordance with the specific design of the additional longitudinally extendingtrack4band themating opening2binpartition wall2, thepiston rod4 is rotationally guided as a function of axial displacement of the piston rod. To obtain apiston rod4 which is longitudinally displaceable while being rotationally locked relative to the housing, the additional longitudinally extendingtrack4bis formed as a rectilinear track which extends parallel to the axis of thepiston rod4. Alternatively, to obtain apiston rod4 which is being rotated as a function of axial displacement of thepiston rod4, the additionallongitudinal track4bis formed as a helical groove or thread which mates and engages with helical ribs or threads formed inopening2bin thepartition wall2.

In accordance with the specific design of the injection device, thefirst thread4aand the additional longitudinally extendingtrack4bmay be disposed on opposite ends of thepiston rod4, may be partly overlapping or fully overlapping in the axial direction of thepiston rod4. Furthermore, thethread4amay be disposed with a larger depth than the additional longitudinally extendingtrack4bor vice versa. InFIG. 1, thethreads4aand4band the threadedopening2bare schematically represented.

Concentrically with thehousing1 thewall2 carries on its side turning away from the compartment3 atubular element5 which is at a part of it adjacent to thewall2 provided with anouter thread6 and which has at its free end acircumferential recess7. A ring shapedcoupling element8 on agear box9 engages therecess7. By this coupling the gearbox is fixed in thehousing1 in a way that allows thegearbox9 to rotate in the housing but not to be axially displaced relative to said housing.

In the gearbox9 a gear wheel assembly comprising two integral gear wheels is journaled on ashaft11, which runs perpendicular to the longitudinal axis of the device between two axial connection bars12. The connection bars12 project from the gear box towards thepartition wall2 and are connected to anut13 which engages thefirst thread4aof thepiston rod4. The gear wheel assembly comprises agear wheel14 with a large diameter engaging the teeth of arack15 which is guided in the gear box to be displaced in the longitudinal direction of the device, and agear wheel16 with a small diameter engaging arack10 inFIG. 2 extending in the longitudinal direction of the device on the inner wall of thegearbox9. Thegear wheel16 with the small diameter may be divided into two gear wheels placed on each side of the of thegear wheel14, and the rack on the inner wall of thegearbox9 may have a longitudinal recess without any teeth to make room for thegear wheel14.

A tubulardose setting member17 fitting into thehousing2 is at an end provided with an internal thread mating and engaging theouter thread6 of thetubular element5 and has at its other end a part with enlarged diameter forming adose setting button18. Due to the engagement with thethread6 thedose setting member17 may be screwed in and out of the housing to show a number on a not shown helical scale on its outer surface in a not shown window in thehousing1.

A bottom19 in a deep cup shaped element, which has atubular part20 fitting into thedose setting member17 and encompassing thegearbox9, forms an injection button. Coupling means between thedose setting member17 and the cup shaped element ensures that rotation of thedose setting member17 is transmitted to the cup shaped element. Further the inner wall of thetubular part20 haslongitudinal recesses22 engaged byprotrusions23 on thegearbox9 so that rotation of thedose setting member17 via the cup shaped element is transmitted to thegearbox9.

At the edge of the open end of the cup shaped element a rosette of V-shaped teeth are provided, which teeth engage a corresponding rosette of V-shapedteeth24 on acoupling member25 which is pressed against the edge of the cup shaped element by aspring26 which is compressed between a not toothed side of thecoupling member25 and around going shoulder27 on the inner wall of thedose setting member17 at an inner end of the inner thread of this member. Thecoupling member25 is provided with one or more inner protrusions forming athread28, which is engaged by a thread or track37 on thetubular element5 so that thecoupling member25 will be forced to rotate when it is displaced axially relative to the housing. The track37 may be designed as a helical thread with a constant pitch along the extension of the track. Alternatively, the layout of the pitch may be formed with a variable pitch along the extension of the track, e.g. by forming a track with inclined as well non-inclined rectilinear steps, or curved parts.

The track37 is so shaped that thedose setting member17 rotates relative to thecoupling member25, when a user dials a dose by rotating thedose setting button18. In this way a click coupling is established which makes a click noise when the V-shaped teeth at the edge of the cup shaped element by rotation of this element rides over the V-shaped teeth of thecoupling member25, i.e. an incremental feedback mechanism is provided.

Ahead29 on the projecting end of therack15 is with a play fixed at the bottom of the cup shaped element between the bottom19 forming the injection button and aninner wall30 near this bottom. The rack is fixed in a position with its head pressed against thewall30 by aspring31 between the bottom19 and thehead29.

To set a dose thedose setting button18 is rotated to advance the dose-settingmember17 in the proximal direction in accordance with thethread6. Due to thecoupling21 the cup shaped element will follow the rotation of the dose-settingmember17 and will be lifted concurrently with this member up from the end of thehousing1. During dose setting, the respective amount of axial displacement of thedose setting member17 and theinjection button19 depends on the pitch of thethread6, the pitch of the first thread on thepiston rod4 and the gear ratio. Also, if thepiston rod4 is allowed to move during dose setting, the axial and rotational movement of thepiston rod4 influences the amount that the injection button will be displaced. By the rotation of the cup shaped element the V-shapedteeth24 at the edge of its open end will ride over the V-shaped teeth of thecoupling member25 to make a click sound for each unit the dose is changed. A too high set dose can be reduced by rotating thedose setting button18 in the opposite direction of the direction for increasing the dose. When the dose setting member is screwed along thethread6 on thetubular element5, thecoupling member25 will follow the dose setting member in its axial movement as thespring26 is supported on theshoulder27. The spring will keep the V-shaped teeth of thecoupling member25 and the cup shaped element in engagement and maintain in engagement thecoupling21, which may comprise Δ-shapedprotrusions32 on the cup shaped element engaging A-shaped recesses in aninner ring33 in thedose setting button18.

Due to the axial displacement of thedose setting member17 during dose setting, thecoupling member25 is axially displaced as well. According to the specific design of the threads ortracks28 and37, thecoupling member25 is forced to rotate as thecoupling member25 is axially displaced. In some embodiments, the thread37 is formed as a helical thread which has a constant pitch along the length of the total axial distance that the coupling member is allowed to move. Depending on the direction of rotation of track37, thedose setting button18 has to be rotated a larger or smaller angle for each click to occur compared to a situation where the coupling member is kept rotationally fixed. A corresponding amendment of the layout of the scale reading may be provided, e.g. by forming the dose scale with larger or smaller spaces between neighboring dose values.

The rotation of thedose setting button18 and the cup shaped element is further transmitted to thegearbox9 through theprotrusions23 on this gearbox engaging thelongitudinal recesses22 in the inner wall of thetubular part20 of said cup shaped element. The rotation of thegearbox9 is through the connection bars12 transmitted to thenut13, which in this way is advanced along thefirst thread4aof thepiston rod4 and lifted away from its abutment with thewall2 when a dose it set. As the dose is set by moving thenut13 on the piston rod which operates the piston in the not shown ampoule in thecompartment3, a dose setting limiter, which ensures that the size of the set dose does not exceed the amount of medicament left in the ampoule, can easily be established by providing thepiston rod4 with astop35 which limits the movement of thenut13 up along thepiston rod4.

Due to the confinement of thehead29 in the space between the bottom19 and thewall30 of the cup shaped element, therack15 is drawn with the injection button outward. Depending on the specific gear ratio of the gear assembly, the outward movement of therack15 corresponds to an outward movement ofnut13. As thenut13 is rotated during dose setting, the length of the piston rod/nut assembly is prolonged, depending on the mutual pitch of the piston rod/nut threads and depending on the actual design of the additional longitudinally extendingtrack4b. By varying the pitch of the different threads or the gear ratio, the piston rod is either moved distally, proximally or held stationary during dose setting.

Ideally, if no axial movement of thepiston rod4 is wanted during dose setting the pitch of thethread6 and the thread formed in thepiston rod4aas well as the pitch of the outer recess (6) should be matched exactly to the gearing ratio of the gear box depicted inFIG. 2.

However, tolerances in the machining of the components comprising the pen may lead to a slight unintended mismatch of the pitches relatively to the transmission ratio of thegearbox9. Especially the situation where thepiston rod4 advances slightly during dose setting is highly undesirable as the injection device during dose setting will expel a small amount of medication.

This situation is avoided by mismatching one or more of the above mentioned pitches to the transmission ratio of the gearbox such that thepiston rod4 is slightly withdrawn during dose setting. The mismatch of pitches is most simply implemented by modification of the pitch of therecess4amade in thepiston rod4 and the corresponding thread in thenut13. In addition, if the additional longitudinally extendingtrack4bon piston rod forms a helical thread, i.e. allowing thepiston rod4 to rotate with respect to the housing (1), this threaded connection has to be taken into account when designing the mechanism.

Alternatively, the injection device is designed such that the recess in the piston rod is initially designed to be axially aligned with the piston rod. On assembled production prototypes the advance of the piston rod during dose setting is measured. Hereafter the axial aligned recess is redesigned to a helical recess where the superimposed rotation of the piston rod during dose setting compensates for the tolerances in the machining.

According to one embodiment of the invention the pitches of the threaded parts and the linear gearing are matched such that the piston rod retracts between 0% and 2% of the full linear translation relatively to the cartridge during dose setting.

A corresponding solution can be provided in the injection device shown in U.S. Pat. No. 6,663,602 which contains an injection device having acoupling member25, which is kept rotationally locked with respect to the housing. For that particular injection device, a slight mismatch of either thethread6 or the thread ofpiston rod4 to the transmission ratio of the gearbox can be provided such that thepiston rod4 is slightly withdrawn during dose setting.

In the device according to the instant invention, to inject a set dose the injection button is pressed by pressing on the bottom19. In the initial phase of the pressing, thespring31 is compressed where after the pressing force is directly transmitted to thehead29 of therack15 and this way to therack15 itself. Through thegear box9 the force is transformed and is transmitted through the connection bars12 to thenut13 which will press thepiston rod4 into thecompartment3 until the dose-settingmember17 abuts thewall2.

During the initial phase of the movement of the injection button the Δ-shapedprotrusions32 on the cup shaped element will be drawn out of their engagement with the Λ-shaped recesses in thering33. The dose-settingmember17 can now rotate relative to the injection button and will do so when the Δ-shapedprotrusions32 press against ashoulder34 at the bottom of thedose setting button18. Only a force sufficient to make the dose setting member rotate to screw itself downward along thethread6 is necessary as the force necessary to make the injection is transmitted to thepiston rod4 through thegearbox9. Ahelical reset spring36 concentric with the dose setting member can be mounted at the lower end of this member and can have one end anchored in thedose setting member17 and the other end anchored in thewall2. During setting of a dose this spring may be tighter coiled so that on the dose setting member it exerts a torque approximately corresponding to the torque necessary to overcome the friction in the movement of the dose setting member along thethread6 so that the force which the user have to exert on the injection button is only the force necessary to drive the piston rod into an ampoule to inject the set dose.

It shall be noticed that use of only one size gear wheel which engages as well therack15, which is movable relative to thegear box9, as therack10, which is unmovable relative to the gear box, provides a gearing ratio of 2:1 for the longitudinal movement relative to thesyringe housing1 for themovable rack15 and theconnector12, which carries theshaft11 of the gear wheel.

FIGS. 3 and 4 shows an embodiment wherein only one size gear wheel is used and wherein elements corresponding to elements inFIGS. 1 and 2 are given the same references as these elements with a prefixed “1”.

For manufacturing reasons minor changes are made. So thepartitioning wall102 and thetubular element105 are made as two parts which are by the assembling of the device connected to each other to make the assembled parts act as one integral part. The same way thedose setting member117 and thedose setting button118 are made as two parts, which are fixed firmly together.

Acircumferential recess107 is provided as an outer recess at the free end of thetubular part105 and a ring shaped coupling element is provided as aninner bead108 on thegearbox element109 which bead engages therecess107 to provide a rotatable but not axially displaceable connection between thetubular part105 and the gearbox.

Atubular element120 havingridges122 which engagesrecesses123 on the gearbox is at its upper end closed by abutton119 from which a force provided by pressing this button is transmitted to thetubular element120.

The gearbox is formed by two shells, which together form a cylinder fitting into the tubular element where the shells are guided by the engagement between theridges122 and therecesses123.Racks110 and115 are provided along edges of the shells facing each other. One shell forming thegearbox part109 is provided with theinner bead108, which engages thecircumferential recess107 at the end of the centraltubular part105 and carries therack110. The other shell is axially displaceable in thetubular element120 and forms therack115. At its outer end projecting from the gearbox the shell carrying therack115 is provided with aflange140 which is positioned in a cut out141 in the end of thetubular element120 carrying thebutton119 so that this button and thetubular element120 can be moved so far inward in the device that the engagement of theteeth132 and133 can be released before thebutton119 abuts theflange140.

Atubular connection element112 connects the threadedpiston rod104 with the gearbox. At its end engaging thepiston rod104 the connection element has anut113 with an internal thread mating theexternal thread104aof thepiston rod104. At its end engaging the gear box the connection element is provided with twopins111 projecting perpendicular to the longitudinal axis of theconnection element112 at each side of this element. Eachpin111 carries agear wheel114 which is placed between and engages the tworacks110 and115. This way theconnection element112 will be rotated with the gear box but can be displaced axially relative to said gear box when theracks110 and115 are moved relative to each other. In practice it will be therack115, which is moved relative to thegearbox element109 and thehousing1 and will by the shown construction result in a movement of theconnection element112 relative to housing a distance which is half the distance which therack115 is moved. Acoupling member125 which is at its periphery provided with a rosette ofteeth124 and has a central bore fitting over the central tube in thehousing101 so that thiscoupling member125 can be axially displaced along saidcentral tube105. One or moreinternal protrusions128 on the central bore of thecoupling member125 is shown inFIGS. 3 and 4. The protrusions engage mating helical recessed tracks or threads137 (not shown inFIGS. 3 and 4) in the central tube to make thecoupling member125 confined with respect to rotational movements, that is, thecoupling member125 being angularly moved in accordance with the axial displacement of thecoupling member125 along the tracks orthreads137. Due to this rotational confinement or rotational guiding in the housing, a rosette of teeth at the edge of thetubular element120 can click over theteeth124 of the coupling member when said tubular element is rotated together with thedose setting member117. Aspring126 working between thecoupling member125 and aninternal shoulder127 provided in thedose setting member117 makes the coupling member follow thetubular element120 when this element with the dose setting member is moved longitudinally in the housing. To make the dose setting member easy rotatable, especially when said dose setting member is pressed inward in the housing, a roller bearing having anouter ring142 supported by theshoulder127 and aninner ring143 supporting apressure bushing144 which supports thespring126. By the provision of this smooth running support only very small axial forces are needed to rotate thedose setting member117 back to its zero position when a set dose is injected. This solution replaces the provision of a reset spring as thespring36 inFIG. 1. The bearing is shown as a radial bearing but can be replaced by an axial bearing.

Whereas thetrack137 is not shown inFIGS. 3 and 4, this track can be viewed inFIG. 5 which depicts an exploded view of the embodiment shown inFIGS. 3 and 4. The centraltubular part105 is further shown in a greater scale inFIG. 6awhileFIG. 6bthe corresponding part of prior art injection shown in U.S. Pat. No. 6,663,602.

Table 1 is a list showing different configurations of the above-described injection device. In table 1, configuration no. 1 corresponds to the device which is disclosed in U.S. Pat. No. 6,663,602, i.e. a device having a piston rod that is non-rotational but axially displaceable and having atrack37,137 which is a rectilinear track which extends parallel to the axis of the injection device. Configurations no. 2-6 correspond to embodiments having the same pitch of thethreads6,106 on the dose setting member and thefirst thread4a,104aon the piston rod as in configuration no. 1. In configuration no. 2-6, thetrack37,137 is formed as a helical track having a constant pitch along the extension of the track, each of the configurations corresponding to specific pitches of the track. Configurations 1-4 have a piston rod that is non-rotational but axially displaceable. Configurations no. 5 and 6 has ahelical track4b,104bwhich mates and engages the threadedopening2bin the housing.

TABLE 1
		Pitch (28, 128) on
	Pitch of dose setting	coupling member	Pitch of piston rod	Pitch of piston rod
	member relative to	relative to housing	relative to nut (13,	relative to housing
	housing	Second pitch on	113)	Second pitch (4b,
	First pitch (6, 106) on	the tubular part	First pitch (4a, 104a)	104b) on the pis-
Configuration	the tubular part	(37, 137)	on the pistonrod	ton rod

1	7.2	0	3.6	0
2	7.2	−14.4	3.6	0
3	7.2	−7.2	3.6	0
4	7.2	14.4	3.6	0
5	7.2	−7.2	3.6	−3.6
6	7.2	−14.4	3.6	−7.2
(Positive pitch values indicates left handed threads, negative pitch values indicates right handed threads, 0 (Zero) indicates a non rotational longitudinally track).

TABLE 2
			Output
		Input	Relative rotation between	Output
		Rotation of the dose	the dose setting member	Delivered axial dis-
Example		setting member (17,	and the coupling member	placement of the piston
#	Configuration	117) (in degrees)	(25, 125) (in degrees)	rod (4, 104) (in mm)

1	1	15	15	0.15
2	2	10	15	0.15
3	3	7.5	15	0.15
4	3	15	30	0.3
5	4	30	15	0.15
6	5	7.5	15	0.075
7	6	10	15	0.1

Table 2 lists examples with different dose settings for the configurations 1-6 wherein the third column of table 2 shows the angular amount that thedose setting drum17,117 has been dialed. Corresponding rotational movement of the dose setting drum relative to thecoupling member25,125 is listed incolumn 4 and the resulting axial displacement of the piston rod is listed incolumn 5.

Comparing examples 1-3 and 5 in table 2, it becomes clear that variation of the pitch oftrack37,137 changes the amount of the rotation that the dose setting member has to be dialed in order to expel a desired dose. Thereby an easy adjustment method is provided where the amount that the dose setting member has to be rotated for advancing the dose setting button one click, can be altered. Also, this provides the possibility of changing the angular distance between consecutive numbers on the dose scale. Hence, to obtain a dose scale layout with enlarged font size or, alternatively, a decreased font size, the pitch of thetrack37,137 is chosen in accordance herewith.

Comparing example 3 and 6, it is readily apparent that introducing a threaded coupling between the piston rod and the housing, i.e. making the piston rod rotatable with respect to the housing, provides for the possibility of obtaining an injection device with altered dosing amounts, e.g. a half-increment injection device.

When introducing acoupling member25,125 that rotates relative to the housing, the end-of-content mechanism as described above may not work in an optimal way. However, by choosing the same pitch for the additional longitudinally extendingtrack4b,104bon the piston rod as for the pitch of thetrack37,137 it is ensured that the end-of-content limitation that the user may experience when setting a dose for injection, corresponds to the exact amount that will be expelled during dosing. In this way, a cartridge may be fully emptied when injecting the dose which corresponds to the end-of-content setting, i.e. the situation where thepiston rod4,104 is fully retracted relative to thenut13,113.

In further embodiments, thetrack37,137 may be designed to have a varying pitch along the track, i.e. having linear parts with inclined or non-inclined stretches as well as curved stretches. Also, the rotational direction of the track may be changed from one part of the track to another part of the track. One specific embodiment may be designed for larger relative dose button movements for small dose settings than for dose settings corresponding to large doses. Thereby it is ensured that the resolution for small dose settings is held at a comparative high level.

Although the above described embodiments show different specific gearbox assemblies, it is to be noted that, within the scope of the present invention, various other types of gearboxes can be used. Also, the functionality of the gearbox can be omitted while the injection device still being within the scope of the present invention.

In addition, alternative embodiments having a dose setting member which is kept axially fixed during dose setting/dosing will be applicable with the present invention and within the scope of the appended claims. One non-limiting embodiment comprises an additional slave member which is rotationally coupled to the dose setting member, and which can be used for inducing axial movement on the coupling member during dose setting.

Further, a frictional coupling may be provided instead of the above-described incremental feed-back mechanism, whereby doses may be set among a continuous selection of dose amounts.

All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein (to the maximum extent permitted by law).

All headings and sub-headings are used herein for convenience only and should not be construed as limiting the invention in any way.

The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.

This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.

Claims (21)

The invention claimed is:

1. An injection device comprising:

a. a housing for a dose setting and injecting mechanism, the housing having a proximal end and a distal end,

b. a rotatable dose setting member,

c. an axially displaceable piston rod having a first thread and an additional longitudinally extending track,

d. a central opening in the housing for engaging the additional longitudinally extending track of the piston rod, thus controlling or restricting angular movement of the piston rod during axial translation of the piston rod,

e. a threaded nut engaging the first thread of the piston rod, the nut being rotatably locked to the dose setting member during dose setting,

f. a rotational coupling mechanism having a coupling member which is axially displaceable from a first position to a second position, the rotational coupling mechanism allowing angular movement of the nut relative to the coupling member during dose setting while preventing angular movement between the nut and the coupling member during injection,

wherein the coupling member is angularly coupled to the housing so as to be forced to move angularly as a function of axial displacement of the coupling member relative to the housing during at least a part of the axial displacement from said first to said second position.

2. The injection device as defined inclaim 1, wherein the dose setting member is axially displaceable as a result of rotation of the dose setting member relative to the housing, and that the coupling member is so coupled to the dose setting member that axial displacement of the dose setting member substantially corresponds to axial displacement of the coupling member.

3. The injection device as defined inclaim 1, wherein the coupling member has a thread and is threadedly engaged with a helical thread disposed in the housing, the thread of the housing having a constant pitch.

4. The injection device as defined inclaim 1, wherein the coupling member has a protrusion which mates and engages a longitudinally extending track disposed in the housing the longitudinally extending track having a variable pitch along the extension of the track.

5. The injection device as defined inclaim 1, wherein the rotational coupling mechanism comprises an incremental feedback mechanism providing incremental clicks during dose setting corresponding to dose volume.

6. The injection device as defined inclaim 1, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

7. The injection device as defined inclaim 6, wherein the gear box assembly provides a gearing causing the nut to move a distance in the distal direction during injection that is less than the distance moved by the injection button.

8. The injection device as defined inclaim 1, wherein the additional longitudinally extending track on the piston rod is helically disposed thereby forming a second thread on the piston rod.

9. The injection device as defined inclaim 8, wherein the first thread and the longitudinally extending track on the piston rod are oppositely disposed.

10. The injection device as defined inclaim 8, wherein the coupling member has a thread and is threadedly engaged with a helical thread disposed in the housing, the thread of the housing having a constant pitch substantially corresponding to the pitch of the additional longitudinally extending track on the piston rod.

11. The injection device as defined inclaim 2, wherein the coupling member has a thread and is threadedly engaged with a helical thread disposed in the housing, the thread of the housing having a constant pitch.

12. The injection device as defined inclaim 2, wherein the coupling member has a protrusion which mates and engages a longitudinally extending track disposed in the housing the longitudinally extending track having a variable pitch along the extension of the track.

13. The injection device as defined inclaim 9, wherein the coupling member has a thread and is threadedly engaged with a helical thread disposed in the housing, the thread of the housing having a constant pitch substantially corresponding to the pitch of the additional longitudinally extending track on the piston rod.

14. The injection device as defined inclaim 2, wherein the rotational coupling mechanism comprises an incremental feedback mechanism providing incremental clicks during dose setting corresponding to dose volume.

15. The injection device as defined inclaim 3, wherein the rotational coupling mechanism comprises an incremental feedback mechanism providing incremental clicks during dose setting corresponding to dose volume.

16. The injection device as defined inclaim 4, wherein the rotational coupling mechanism comprises an incremental feedback mechanism providing incremental clicks during dose setting corresponding to dose volume.

17. The injection device as defined inclaim 2, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

18. The injection device as defined inclaim 3, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

19. The injection device as defined inclaim 4, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

20. The injection device as defined inclaim 5, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

21. The injection device as defined inclaim 6, wherein the injection device further comprises an injection button and a gear box assembly coupling axial movement of the injection button with axial movement of the nut.

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